JOB DESCRIPTION
Summary:
Independently performs routine lab work, sample analysis, validation, and method development.
Education, Experience, and Skills Required:
- BA/BS or higher with 5-6 years lab experience; all experiences will be evaluated
- Able to perform complex lab work
- Able to work in a regulated environment
- Able to work effectively and contribute within a team
- Able to work with computer systems
- Able to document clearly
- Knowledge of and experience in a regulatory environment
Essential Function:
- Prepare reagents, standards, and control samples
- Analyze samples using various techniques specific to department
- Assist with method development
- Perform method validation or qualification
- Operate analytical equipment
- Lead troubleshooting activities
- Maintain analytical equipment
- Ensure lab area is clean and inspection ready at all times
- Remove lab waste
- Record tasks in accordance with Good Documentation Practices (GDP)
- Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11
- Follow applicable SOPs and procedural documents
- Review and evaluate data results
- Train lower level Scientists
- Other tasks as assigned
Competencies:
- Adaptable
- Exactness
- Flexibility
- Collaborative
- Effective Listener and Communicator
- Capacity to Master and Influence Others
- Results Driven
- Creative and Forward Thinking
- Initiative
- Supportive
- Extend Assistance
- Strategic Minded
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